AstraZeneca Breztri met primary endpoints in Phase III trials in asthma Ruchika Sharma4 May 2025 10:30 AM ISTAstraZeneca has announced the Positive high-level results from the Phase III KALOS and LOGOS trials in patients with uncontrolled asthma showed that...
Glenmark gets CDSCO Panel nod to study Glycopyrronium, Fluticasone Furoate, Vilanterol Powder for Inhalation Dr. Divya Colin10 April 2025 5:45 PM ISTNew Delhi: In line with the revised Phase IV clinical trial protocol of Glycopyrronium 50 mcg plus Fluticasone Furoate 100 mcg plus Vilanterol 25 mcg...
Conduct Phase III CT: CDSCO Panel Tells Zydus Healthcare on Glycopyrrolatem plus Indacaterol metered dose inhalation Dr. Divya Colin24 Nov 2024 5:30 PM ISTNew Delhi: Considering the bioequivalence study report presented by Zydus Healthcare, the Subject Expert Committee (SEC) functional under the Central...
AstraZeneca gets CDSCO Panel nod to study Budesonide, Glycopyrronium and Formoterol Fumarate Dr. Divya Colin20 Oct 2024 5:45 PM ISTNew Delhi: The drug major AstraZeneca has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Include nebulization methodology, nebulizer types: CDSCO Panel Tells Glenmark pharmaceuticals on Pulmonary FDC Dr. Divya Colin14 Jun 2024 6:00 PM ISTNew Delhi: Citing to include nebulization methodology, type of nebulizer, and interface, the Subject Expert Committee (SEC) functional under the...
Lupin Gets CDSCO Panel Nod to Study FDC of Fluticasone, Glycopyrronium, Vilanterol Inhalation Powder Dr. Divya Colin23 Jan 2024 6:00 PM ISTNew Delhi: The drug major Lupin has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Conduct BE study and clinical trial: CDSCO Panel tells Cipla on Formoterol Fumarate Dihydrate, glycopyrronium inhaler Dr. Divya Colin19 Dec 2023 6:58 PM ISTNew Delhi: Rejecting the proposal for clinical trial and bioequivalence (BE) study waiver presented by drug major Cipla, the Subject Expert Committee...
Conduct bioequivalence study: CDSCO Panel Tells Lupin on FDC Indacaterol, Glycopyrronium inhalation powder Dr. Divya Colin28 Nov 2023 6:00 PM ISTNew Delhi: Rejecting the justification for the waiver of the bioequivalence study (BE) and Phase III clinical study of fixed-dose combination (FDC)...
Zydus Healthcare gets CDSCO Panel nod to study Fluticasone Furoate, Glycopyrronium, Vilanterol FDC Dr. Divya Colin22 Oct 2023 6:00 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has approved drug major Zydus...
Lupin Gets CDSCO Panel Nod To Manufacture, Market FDC of Glycopyrronium, Vilanterol Inhalation Powder Dr. Divya Colin5 Sept 2023 6:00 PM ISTNew Delhi: The drug major Lupin has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Submit Supportive Documents for safety of Fluticasone dose: CDSCO panel Tells Glenmark on FDC pulmonary drug Dr. Divya Colin4 Sept 2023 6:00 PM ISTNew Delhi: Based on the Phase III clinical trial protocol and justification for the inhalation toxicity of the fixed-dose combination (FDC) pulmonary...
Glenmark gets CDSCO panel nod to manufacture ,market pulmonary FDC drug Dr. Divya Colin10 April 2023 6:00 PM ISTNew Delhi: The drug major Glenmark has got the go ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
